1 Scope
This standard specifies the terms and definitions, structure and basic parameters, requirements, test methods, inspection rules as well as marking, packaging, transport and storage for the excimer laser cornea ametropia cure system.
Excimer laser cornea ametropia cure system (hereinafter referred to as “cure system”) is mainly used for corner ametropic correction, e.g. photorefractive keratectomy (PRK) and laser assisted in-situ keratomi (LASIK), and photo therapeutic keratectomy (PTK).
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this national standard. For dated references, subsequent amendments to (excluding the corrections), or revisions of, any of these publications do not apply. However, the parties who enter into agreement according to this standard are encouraged to study whether the latest editions of these documents apply. For undated references, the latest edition is applicable to this standard.
GB/T 191-2000 Packaging - Pictorial Marking for Handling of Goods
GB 7247.1-2001 Safety of Laser Products - Part 1: Equipment Classification, Requirements and Users Guide (idt IEC 60825-1:1993)
GB 9706.1-1995 Medical Electrical Equipment - Part 1: General Requirements for Safety (idt IEC 601-1:1988)
GB 9706.20-2000 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment (idt IEC 60601-2-22:1995)
GB/T 14710-1993 The Environmental Requirements and Test Methods for Medical Electrical Equipment
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Structure and Basic Parameters
5 Requirements
6 Test Methods
7 Inspection Rules
8 Marking, Packaging, Transport and Storage
